Phase I trial of the safety and the effect on immune parameters of an immunotherapy for glioma based on cultured autologous dendritic cells presenting autologous tumour cell antigens derived from irradiated glioma cells
Phase 1
Completed
- Conditions
- GlioblastomaCancer - Brain
- Registration Number
- ACTRN12605000423617
- Lead Sponsor
- Queensland Institute of Medical Research (QIMR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Confirmed Malignant Glioma, Macroscopic tumour resection, normal haematolological parameters, acceptable liver and renal function parameters.
Exclusion Criteria
Extensive intracranial disease precluding total or subtotal resection, ECOG status >2, History of autoimmune disease or immunosuppressive therapy, Prior use of immunotherapeutic agent, Positive serology for HIV, Hep B or Hep C, Significant non-malignant disease, Pregnancy, Other malignancy, Patients in whom only biopsy or partial resection was possible.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety[After each vaccine (fortnightly for 6 injections, then 6 weekly for 1 year.) Evaluations will also be performed within 6 weeks of the final vaccination and whenever clinically indicatedor until disease progression). Final analysis will occur by 14 months after the last patient entered into the study had their first vaccination.]
- Secondary Outcome Measures
Name Time Method Clinical efficacy based on the time interval between the first vaccination and disease progression.[Disease progression is assessed at vaccination (fortnightly for 6 injections, then 6 weekly for 1 year, within 6 weeks of the final vaccination and whenever clinically indicated. Final analysis will occur by 14 months after the last patient entered into the study had their first vaccination.]